U.S. patent application number 16/710987 was filed with the patent office on 2020-06-18 for annuloplasty device including tube-like structure.
The applicant listed for this patent is Medtronic Vascular, Inc.. Invention is credited to Caitlin Dorff, Fatemeh Fatemi Far, Matthew E. Genovese, Emily Grimm, Olivia Metcalf, Karan Punga.
Application Number | 20200188110 16/710987 |
Document ID | / |
Family ID | 71072200 |
Filed Date | 2020-06-18 |
United States Patent
Application |
20200188110 |
Kind Code |
A1 |
Metcalf; Olivia ; et
al. |
June 18, 2020 |
ANNULOPLASTY DEVICE INCLUDING TUBE-LIKE STRUCTURE
Abstract
In some examples, the disclosure describes an annuloplasty
device that comprises a tube-like structure configured to extend
around at least part of a circumference of an annulus of a cardiac
or vascular valve of a patient, and at least one anchor configured
to anchor the tube-like structure to the annulus. The tube-like
structure is configured to decrease a distance between valve
leaflets that extend from the annulus.
Inventors: |
Metcalf; Olivia; (Santa
Rosa, CA) ; Punga; Karan; (San Rafael, CA) ;
Genovese; Matthew E.; (Windsor, CA) ; Dorff;
Caitlin; (Santa Rosa, CA) ; Grimm; Emily;
(Petaluma, CA) ; Fatemi Far; Fatemeh; (Santa Rosa,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic Vascular, Inc. |
Santa Rosa |
CA |
US |
|
|
Family ID: |
71072200 |
Appl. No.: |
16/710987 |
Filed: |
December 11, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62779274 |
Dec 13, 2018 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2210/0014 20130101;
A61F 2/2466 20130101; A61F 2220/0016 20130101; A61F 2250/001
20130101; A61F 2230/0091 20130101; A61F 2/2445 20130101; A61F
2230/0069 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An annuloplasty device comprising: a tube-like structure
configured to extend around at least part of a circumference of an
annulus of a cardiac or vascular valve; and at least one anchor
configured to anchor the tube-like structure to the annulus,
wherein the tube-like structure is configured to decrease a
distance between valve leaflets that extend from the annulus.
2. The annuloplasty device of claim 1, wherein the tube-like
structure comprises at least one of a stent, a stent having a
spiral pattern of crowns and connection nodes, or a cut tube having
cuts extending in at least one of circumferential or longitudinal
directions of the cut tube.
3. The annuloplasty device of claim 1, wherein the tube-like
structure has a pre-set shape configured to urge at least some
anchors of the plurality of anchors toward each other in a radially
inward direction to decrease a distance between valve leaflets that
extend from the annulus.
4. The annuloplasty device of claim 1, wherein the tube-like
structure has a pre-set shape configured to urge at least some
anchors of the plurality of anchors away from each other in a
radially outward direction.
5. The annuloplasty device of claim 1, wherein the tube-like
structure is a first tube-like structure, further comprising a
second tube-like structure coaxially arranged within the first
tube-like structure, wherein the second tube-like structure
comprises the at least one anchor, wherein the at least one anchor
extends radially outward through the first tube-like structure, and
wherein the first tube-like structure urges the at least one anchor
to engage with tissue.
6. The annuloplasty device of claim 1, wherein the at least one
anchor is configured to move between an undeployed configuration in
which the at least one anchor extends generally inward into a bore
of the tube-like structure and a deployed configuration in which
the at least one anchor extends generally outward away from the
bore of the tube-like structure.
7. The annuloplasty device of claim 1, wherein the at least one
anchor comprises a spiral anchor configured to extend spirally
through holes in the tube-like structure.
8. The annuloplasty device of claim 1, further comprising a cinch
wire extending through a bore of the tube-like device, wherein the
cinch wire extends through the bore from a first end of the
tube-like device to a second end of the tube-like device.
9. The annuloplasty device of claim 8, wherein the at least one
anchor comprise a first anchor coupled to a first end of the cinch
wire and a second anchor coupled to a second end of the cinch wire,
opposite the first end of the cinch wire.
10. The annuloplasty device of claim 1, further comprising a cinch
device disposed in a bore of the tube-like structure, wherein the
cinch device has a pre-set shape with a smaller radius of curvature
than the tube-like structure.
11. The annuloplasty device of claim 1, further comprising a
removable stylet, wherein the removable stylet comprises a pre-set
shape approximating a shape of the annulus, wherein the removable
stylet is removably disposed in a bore of the tube-like structure,
and wherein removal of the removable stylet from the bore allows
the tube-like structure to recover toward a pre-set shape having a
smaller radius of curvature than a radius of curvature of the
removable stylet.
12. The annuloplasty device of claim 1, wherein the tube-like
structure is configured to extend from adjacent a first trigone to
a second trigone of the cardiac or vascular valve.
13. The annuloplasty device of claim 1, wherein the tube-like
structure is configured to extend around substantially an entire
circumference of the annulus.
14. The annuloplasty device of claim 1, wherein the tube-like
structure is a first tube-like structure configured to extend from
adjacent a first trigone to a second trigone of the cardiac or
vascular valve in a first direction, further comprising a second
tube-like structure configured to extend from adjacent the first
trigone to adjacent the second trigone of the cardiac or vascular
valve in a second direction opposite the first direction.
15. The annuloplasty device of claim 1, wherein the cardiac or
vascular valve comprises a mitral valve comprising a mitral
annulus, an anterior valve leaflet, and a posterior valve leaflet,
and wherein the tube-like structure is configured to extend around
a circumference of the mitral annulus from proximate the anterior
valve leaflet to proximate the posterior valve leaflet.
16. A system comprising: a delivery device configured to access
vasculature of a patient; and an annuloplasty comprising: a
tube-like structure configured to extend around at least part of a
circumference of an annulus of a cardiac or vascular valve; and at
least one anchor configured to anchor the tube-like structure to
the annulus, wherein the delivery device is configured to house the
annuloplasty device in a lumen and deliver the annuloplasty device
to the annulus of the cardiac or vascular valve and engage the
anchors to the annulus, and wherein the tube-like structure is
configured to decrease a distance between valve leaflets that
extend from the annulus.
17. The system of claim 16, wherein the delivery device comprises a
steerable shaft.
18. The system of claim 16, wherein the delivery device is
configured to exert a force on the anchor to engage the anchor with
the annulus.
19. The system of claim 16, wherein the anchor comprises a spiral
anchor configured to extend spirally through holes in the tube-like
structure, and wherein the delivery device is configured to torque
the spiral anchor to advance the spiral anchor in engagement with
the tube-like structure.
20. The system of claim 16, wherein the delivery device is
configured to manipulate a cinch device to reduce a radius of
curvature of the tube-like structure.
21. A method comprising: advancing a delivery device through
vasculature of a patient to a vascular or cardiac treatment site,
wherein the delivery device comprises a lumen housing an
annuloplasty device, wherein the annuloplasty device comprises: a
tube-like structure configured to extend around at least part of a
circumference of an annulus of a cardiac or vascular valve; and at
least one anchor configured to anchor the tube-like structure to
the annulus; wherein the tube-like structure is configured to
decrease a distance between valve leaflets that extend from the
annulus; and releasing the annuloplasty device from the lumen to
extend around at least part of a circumference of an annulus of a
cardiac or vascular valve.
22. The annuloplasty device of claim 21, wherein the tube-like
structure has a pre-set shape, wherein the delivery device is
configured to urge the tube-like structure away from the pre-set
shape, and wherein releasing the annuloplasty device from the lumen
allows the tube-like structure to return toward the pre-set
shape.
23. The annuloplasty device of claim 21, wherein the tube-like
structure is a first tube-like structure, further comprising a
second tube-like structure coaxially arranged within the first
tube-like structure, wherein the second tube-like structure
comprises the at least one anchor, and wherein releasing the
annuloplasty device from the lumen allows the first tube-like
structure to urge the at least one anchor to engage with
tissue.
24. The annuloplasty device of claim 21, wherein the tube-like
structure comprises the at least one anchor, and wherein releasing
the annuloplasty device from the lumen allows the tube-like
structure to deform to urge the at least one anchor to engage with
tissue.
25. The annuloplasty device of claim 21, wherein the tube-like
structure comprises the at least one anchor, wherein releasing the
annuloplasty device from the lumen comprises moving the at least
one anchor between an undeployed configuration in which the at
least one anchor extends generally inward into a bore of the
tube-like structure and a deployed configuration in which the at
least one anchor extends generally outward away from the bore of
the tube-like structure.
26. The annuloplasty device of claim 21, wherein the delivery
device further comprises a balloon catheter, and wherein moving the
at least one anchor between the undeployed configuration and the
deployed configuration comprises expanding the balloon to exert a
force on the at least one anchor.
27. The annuloplasty device of claim 21, wherein the tube-like
structure comprises the at least one anchor, wherein the at least
one anchor is biased to extend in a first direction relative to a
longitudinal axis of the tube-like structure and extend generally
outward away from the bore of the tube-like structure, and wherein
releasing the annuloplasty device from the lumen comprises exerting
a force on the tube-like structure in a direction of the bias to
cause the at least one anchor to engage with tissue.
28. The annuloplasty device of claim 21, wherein the at least one
anchor comprises a spiral anchor configured to extend spirally
through holes in the tube-like structure, and wherein releasing the
annuloplasty device from the lumen comprises torqueing the spiral
anchor with the delivery device to advance the spiral anchor in
engagement with the tube-like structure and engage the spiral
anchor with tissue.
29. The annuloplasty device of claim 21, wherein the annuloplasty
device further comprises a cinch wire extending through a bore of
the tube-like device, and wherein releasing the annuloplasty device
comprises exerting a force on the cinch wire to cause the tube-like
structure to decrease the distance between the valve leaflets that
extend from the annulus.
30. The annuloplasty device of claim 21, wherein the annuloplasty
device further comprises a cinch device disposed in a bore of the
tube-like structure, wherein the cinch device has a pre-set shape
with a smaller radius of curvature than the tube-like structure,
and wherein releasing the annuloplasty device from the lumen allows
the cinch device to urge the tube-like structure toward the smaller
radius of curvature.
31. The method of claim 21, wherein the annuloplasty device further
comprises a removable stylet, wherein the removable stylet
comprises a pre-set shape approximating a shape of the annulus,
wherein the removable stylet is removably disposed in a bore of the
tube-like structure, and wherein releasing the annuloplasty device
from the lumen comprises removing the removable stylet from the
bore to allow the tube-like structure to recover toward a pre-set
shape having a smaller radius of curvature than a radius of
curvature of the removable stylet.
32. The method of claim 21, wherein the cardiac or vascular valve
comprises a mitral valve comprising a mitral annulus, an anterior
valve leaflet, and a posterior valve leaflet, and wherein the
tube-like structure is configured to extend around a circumference
of the mitral annulus from proximate the anterior valve leaflet to
proximate the posterior valve leaflet.
Description
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 62/779,274, filed on Dec. 13, 2018, the
entire content of which is incorporated by reference herein.
TECHNICAL FIELD
[0002] This disclosure relates to heart valve repair, such as
mitral valve repair.
BACKGROUND
[0003] Some patient conditions can produce valvular insufficiency
or regurgitation. Valvular insufficiency or regurgitation occurs
when a valve in a heart of a subject does not close completely,
allowing blood to flow backwards (e.g., from the left ventricle to
the left atrium), which may adversely impact the functionality of
the heart.
[0004] The mitral valve includes two leaflets (anterior and
posterior) attached to an annulus (e.g., a fibrous ring). In a
healthy heart, the mitral valve leaflets close, or coapt, during
contraction of the left ventricle and prevent blood from flowing
back into the left atrium. Mitral valve regurgitation is a
condition in which the leaflets of a mitral valve of a subject do
not coapt properly and, as a result, blood regurgitates back into
the left atrium from the left ventricle. The regurgitation of blood
back into the left atrium may result in a reduced ejection volume
from the left ventricle, causing the heart of the subject to work
relatively hard to supply the desirable volume of blood to the
body. Mitral regurgitation may occur because of different patient
conditions. For example, secondary mitral regurgitation, also
referred to as functional mitral regurgitation, may occur when a
left ventricle dilates and causes dilation of the mitral annulus of
a subject.
SUMMARY
[0005] In some aspects, this disclosure describes example
annuloplasty devices, systems, and techniques for repairing a heart
valve, such as, but not limited to, a mitral valve. The
annuloplasty devices, systems, and techniques enable reduction in
spacing between valve leaflets, may improve coaptation of the valve
leaflets, and may help reduce valvular insufficiency or
regurgitation.
[0006] In some examples the disclosure describes an annuloplasty
device that includes a tube-like structure configured to extend
around at least part of a circumference of an annulus of a cardiac
or vascular valve; and at least one anchor configured to anchor the
tube-like structure to the annulus, where the tube-like structure
is configured to decrease a distance between valve leaflets that
extend from the annulus.
[0007] In some examples the disclosure describes a system that
includes a delivery device configured to access vasculature of a
patient; and the annuloplasty device that includes a tube-like
structure configured to extend around at least part of a
circumference of an annulus of a cardiac or vascular valve; and at
least one anchor configured to anchor the tube-like structure to
the annulus, where the tube-like structure is configured to
decrease a distance between valve leaflets that extend from the
annulus, where the delivery device is configured to house the
annuloplasty device in a lumen and deliver the annuloplasty device
to the annulus of the cardiac or vascular valve and engage the
anchors to the annulus.
[0008] In some examples the disclosure describes a method that
includes advancing a delivery device through vasculature of a
patient to a vascular or cardiac treatment site, where the delivery
device includes a lumen housing an annuloplasty device, where the
annuloplasty device includes a tube-like structure configured to
extend around at least part of a circumference of an annulus of a
cardiac or vascular valve; and at least one anchor configured to
anchor the tube-like structure to the annulus, where the tube-like
structure is configured to decrease a distance between valve
leaflets that extend from the annulus; and releasing the
annuloplasty device from the lumen to extend around at least part
of a circumference of an annulus of a cardiac or vascular
valve.
[0009] The details of one or more examples are set forth in the
accompanying drawings and the description below. Other features,
objects, and advantages of examples according to this disclosure
will be apparent from the description and drawings, and from the
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIGS. 1A and 1B are schematic cross-sectional views of an
example human heart.
[0011] FIG. 2 is a schematic cross-sectional view of an example
human heart and an example annuloplasty device including a
tube-like structure.
[0012] FIG. 3 is a schematic cross-sectional view of an example
human heart and an example annuloplasty device including a first
tube-like structure and a second tube-like structure including a
plurality of anchors.
[0013] FIG. 4 is a schematic cross-sectional view of an example
human heart and an example annuloplasty device including a
tube-like structure that includes a plurality of anchors, with the
plurality of anchors in an undeployed configuration.
[0014] FIG. 5 is a schematic cross-sectional view of an example
human heart and an example annuloplasty device including a
tube-like structure that includes a plurality of anchors, with the
plurality of anchors in a deployed configuration.
[0015] FIG. 6 is an image of an example annuloplasty device
including a tube-like structure and a plurality of anchors that are
biased to engage with tissue.
[0016] FIG. 7 is a line diagram of an example annuloplasty device
including a tube-like structure and a cinching device in a bore of
the tube-like structure.
[0017] FIG. 8 is a schematic view of an example annuloplasty device
including a tube-like structure and a stylet in a bore of the
tube-like structure.
[0018] FIG. 9A is a schematic partial cross-sectional view of an
example human heart and an annuloplasty device including a
tube-like structure, a spiral anchor, and a cinch wire.
[0019] FIG. 9B is a cross-sectional view of the human heart of FIG.
9A illustrating a portion of atrial wall, annulus, and ventricular
wall.
[0020] FIG. 10 is a schematic cross-sectional view of an example
human heart and an annuloplasty device including a first tube-like
structure and a second tube-like structure.
[0021] FIG. 11 is a flow diagram illustrating a technique for
implanting an annuloplasty device.
DETAILED DESCRIPTION
[0022] This disclosure describes annuloplasty devices, systems, and
techniques for repairing a heart valve, such as, but not limited
to, a mitral valve. The annuloplasty devices, systems, and
techniques enable reduction in spacing between valve leaflets, may
improve coaptation of the valve leaflets, and may help reduce
valvular insufficiency or regurgitation. Annuloplasty devices may
include a tube-like structure and at least one anchor. The at least
one anchor may be configured to engage the tube-like structure and
tissue of an annulus of the heart valve or trigone of the heart
valve to fix the tube-like structure to the tissue. The tube-like
structure may be configured to exert a force on the tissue to urge
the valve leaflets toward each other and improve coaptation of the
valve leaflets.
[0023] In some examples, the at least one anchor is integral with
the tube-like structure. For example, the at least one anchor may
include tines or projections that are part of the tube-like
structure and extend radially outward from the tube-like structure
to engage tissue. In other examples, the at least one anchor is
separate from the tube-like structure. For example, the at least
one anchor may include a spiral anchor that spirally engages holes
in the tube-like structure. As another example, the at least one
anchor may include a second tube-like structure that is disposed in
a bore of the first tube-like structure.
[0024] In some examples, the annuloplasty device may include a
cinch device or a cinch wire. The cinch device or cinch wire may be
configured to enable the tube-like structure to exert a force on
the anchors to reduce spacing between the valve leaflets.
[0025] FIGS. 1A and 1B are schematic cross-sectional views of an
example human heart 10. The human heart 10 is a four chambered,
muscular organ that provides blood circulation through the body
during a cardiac cycle. The four main chambers are the right atrium
(RA) and right ventricle (RV) which supplies the pulmonary
circulation, and the left atrium (LA) and left ventricle (LV) which
supplies oxygenated blood received from the lungs to the remaining
body. To ensure that blood flows in one direction through the
heart, atrioventricular valves (tricuspid valve (TV) and mitral
valve (MV)) are present between the junctions of the atrium and the
ventricles, and semi-lunar valves (pulmonary valve (PV) and aortic
valve (AV)) govern the exits of the ventricles leading to the lungs
and the rest of the body. These valves contain leaflets (LF) or
cusps that open and shut in response to blood pressure changes
caused by the contraction and relaxation of the heart chambers.
FIG. 1B is a schematic sectional illustration of a left ventricle
LV of heart 10 showing anatomical structures and a native mitral
valve MV.
[0026] The left atrium LA receives oxygenated blood from the lungs
via the pulmonary veins and pumps the oxygenated blood through the
mitral valve MV and into the left ventricle LV during ventricular
diastole. The left ventricle LV contracts during systole and blood
flows outwardly through the aortic valve AV, into the aorta and to
the remainder of the body. In a healthy heart, the leaflets LF of
the native mitral valve MV meet evenly at the free edges or "coapt"
to close and prevent back flow of blood into the left atrium LA
during contraction of the left ventricle LV. The tissue of the
leaflets LF attach to the surrounding heart structure via a dense
fibrous ring of connective tissue called an annulus AN. The
flexible tissue of the leaflets LF of the native mitral valve MV
are connected to papillary muscles PM, which extend upwardly from
the lower wall of the left ventricle LV and the interventricular
septum IVS, via branching tendons called chordae tendinae CT.
[0027] Mitral valve regurgitation is a condition in which the
leaflets of a mitral valve of a subject do not coapt properly and,
as a result, blood regurgitates back into the left atrium LA from
the left ventricle LV. The regurgitation of blood back into the
left atrium LA may result in a reduced ejection volume from the
left ventricle LV, causing the heart of the subject to work
relatively hard to supply the desirable volume of blood to the
body. Mitral regurgitation may occur because of one or more patient
conditions. For example, secondary mitral regurgitation, also
referred to as functional mitral regurgitation, may occur when the
left ventricle LV dilates and causes dilation of the mitral annulus
of a subject. The leaflets LF of the valves may move apart as a
result of the dilation of the left ventricle LV, which may
adversely impact the ability of the leaflets to properly coapt.
[0028] In addition to or instead of being caused by dilation of the
left ventricle LV, mitral valve regurgitation (or other valve
regurgitation) may be caused by calcified plaque buildup in heart
10. For example, the leaflets LF of the valves (e.g., aortic valve
AV or mitral valve MV) may harden and may not sufficiently coapt or
meet, such that regurgitation may occur where the valve does not
close completely, allowing blood to flow backwards (e.g., from the
left ventricle LV to the left atrium LA). The left side of heart 10
(e.g., mitral valve MV and aortic valve AV) can be more likely to
become calcified because of the higher pressures generated.
[0029] The medical devices, systems, and techniques described
herein may be used to repair a valve of heart 10 via a minimally
invasive medical procedure, e.g., via a transcatheter, trans-septal
medical procedure that is less invasive than open heart surgery.
While open heart surgeries, such as annuloplasty performed via open
heart surgery, may have positive outcomes, a more minimally
invasive medical procedure may also have positive outcomes while
also being associated with a shorter recovery time for some
patients compared to open heart surgery.
[0030] Although example devices, systems, and techniques are
primarily described herein with reference to the mitral valve MV,
in other examples, the example devices, systems, and techniques may
be used to repair other valves in heart 10. Further, while various
features are described with respect to different figures, it will
be understood that features from different figures may be combined,
separated, used together, or used separately across all examples
shown and described.
[0031] FIG. 2 is a schematic cross-sectional view of an example
human heart 10 and an example annuloplasty device 20 including a
tube-like structure 22. FIG. 2 is a top cross-sectional view of
human heart 10 showing the annulus AN of mitral valve MV (FIGS. 1A
and 1B) and leaflets LF. Leaflets LF may include an anterior
leaflet and a posterior leaflet.
[0032] Tube-like structure 22 may include a biocompatible material
in a tubular shape that is configured to apply or maintain a force
on annulus AN and/or leaflets LF to urge leaflets LF toward each
other and improve coaptation of leaflets LF. In some examples,
tube-like structure 22 may include a biocompatible metal or alloy,
such as nitinol, stainless steel, a cobalt-chromium alloy, or the
like. In some instances, tube-like structure 22 may include a
biocompatible shape memory alloy.
[0033] Tube-like structure 22 may include a stent, a cut tube
(e.g., a laser cut tube), or a tube created by joining individually
formed elements. In any case, tube-like structure 22 may include a
sidewall defining the shape of tube-like structure 22 and defining
a bore (e.g., an inner lumen). In some examples, the bore may
extend the length of tube-like structure from a proximal end of
tube-like structure 22 to a distal end of tube-like structure 22.
The sidewall may be shaped and sized such that another device, such
as a cinch wire, a cinch device, a second tube-like structure, or
the like, may extend through the bore for at least a portion of a
length of tube-like structure 22.
[0034] In examples in which tube-like structure 22 includes a
stent, the stent may include any suitable stent construction. For
example, the stent may include a plurality of interwoven filaments
that together define the sidewall of tube-like structure 22. As
another example, the stent may include a spiral pattern of crowns
and connection nodes configured to provide predetermined
flexibility to tube-like structure 22. The spiral pattern of crowns
and connection nodes may be formed by cutting a tube to remove
material and leave the spiral pattern of crowns and connection
nodes. As another example, the stent may include another suitable
arrangement of struts.
[0035] A cut tube may include at least one cut that serves to
selectively increase flexibility of the cut tube. The cuts may be
oriented in a circumferential direction, a longitudinal direction,
or the like. In some examples, the cuts may include spiral cut(s)
that extend around a circumference of tube-like structure 22
resulting in the cut tube having a spiral or helical shape. In some
examples, the cuts may additionally or alternatively include
apertures or through holes configured to receive an anchor to
anchor tube-like structure 22 to annulus AN and/or leaflets LF.
[0036] In some examples, tube-like structure 22 may have a pre-set
shape. For example, the pre-set shape may be defined using a heat
treatment. The pre-set shape is a shape toward which tube-like
structure 22 recovers in the absence of an applied force. In some
examples, the pre-set shape may include a radius of curvature
larger than a curvature of annulus AN, such that the pre-set shape
urges tube-like structure 22 radially outward toward walls of
annulus AN to enable tube-like structure 22 to more closely follow
the shape of annulus AN. In other examples, the pre-set shape may
include a radius of curvature smaller than a curvature of annulus
AN, such that the pre-set shape urges tube-like structure 22
radially inward toward coaptation surfaces of leaflets LF. When
tube-like structure 22 is anchored to annulus AN and/or leaflets
LF, the pre-set shape that urges tube-like structure 22 radially
inward toward may exert a force on annulus AN and/or leaflets LF to
increase coaptation of leaflets LF.
[0037] Tube-like structure 22 is configured to extend along a
predetermined length of annulus AN. In some examples, tube-like
structure 22 may extend from a first trigone attached to annulus AN
to a second trigone attached to annulus AN. In other examples,
tube-like structure 22 may extend from adjacent to a first leaflet
LF to a second leaflet LF. In still other examples, tube-like
structure 22 may extend substantially around a perimeter of annulus
AN.
[0038] Annuloplasty device 20 also includes at least one anchor 24.
At least one anchor 24 may include any structure configured to
engage tube-like structure 22 to annulus AN and/or leaflets LF and
retain tube-like structure 22 substantially in place relative to
annulus AN and/or leaflets LF. In some examples, at least one
anchor 24 includes a plurality of anchors, and respective anchors
of the plurality of anchors may be positioned along a length of
tube-like structure 22. In other examples, at least one anchor 24
may include a single anchor that extends along at least part of a
length of tube-like structure 22.
[0039] In some examples, at least one anchor 24 includes a helix or
double helix that is configured to be advanced into tissue of heart
10, e.g., annulus AN and/or leaflets LF. The helix or double helix
may optionally include an attachment, such as a hook, loop, or the
like that is configured to engage tube-like structure 22 or another
portion of annuloplasty device 20 to substantially retain tube-like
structure 22 relative to the anchor 24. In this way, the at least
one anchor 24 may be configured to substantially retain tube-like
structure 22 relative to a location of tissue of heart 10, such as
a location of annulus AN and/or leaflets LF. At least one anchor 24
thus allows application of force form tube-like structure 22 to
tissue of heart 10 at selected locations of heart 10.
[0040] FIG. 2 also illustrates a delivery device 26 for
annuloplasty device 20. In the example of FIG. 2, delivery device
26 includes a catheter. The catheter may define an internal lumen
that extends from proximate a proximal end of the catheter to
proximate a distal end of the catheter (e.g., may extend from the
proximal end to the distal end). The lumen may be configured to
house annuloplasty device 20 during percutaneous introduction of
the catheter into vasculature of a patient and advancing of the
distal end of the catheter to the treatment location, such as the
left atrium LA. In some examples, the catheter may be used with a
guidewire, a guide catheter, or the like, to facilitate
introduction of the catheter into vasculature of a patient and
advancing of the distal end of the catheter to the treatment
location. In some examples, the catheter includes a steerable shaft
and/or distal tip to allow a clinician to control positioning of
the distal tip relative to anatomical structures, such as heart 10.
In some implementations, the catheter may access left atrium LA
trans-septally.
[0041] The catheter is also configured to deploy annuloplasty
device 20, e.g., tube-like structure 22 and at least one anchor 24
in position proximate annulus AN and engage the at least one anchor
24 with tissue of heart 10, e.g., with annulus AN and/or leaflets
LF. In some examples, to facilitate positioning of the catheter,
annuloplasty device 20, or both, within the treatment location, a
distal portion of the catheter may include at least one
radiographic marker configured to be visualized using a
radiographic technique.
[0042] Annuloplasty device 20, including tube-like structure 22 and
at least one anchor 24 may be formed in any one or more of a
variety of configurations. FIGS. 3-10 are conceptual diagrams
illustrating various aspects of examples of tube-like structure 22
and at least one anchor 24. Although features of annuloplasty
device 20 are described with reference to different examples, it
will be appreciated that features of the annuloplasty devices
described herein, including those illustrated in FIGS. 3-10, may be
used in any combination.
[0043] FIG. 3 is a schematic cross-sectional view of an example
human heart 10 and an annuloplasty device 30 including a first
tube-like structure 32 and a second tube-like structure 36
including a plurality of anchors 38. Second tube-like structure 36
may be arranged coaxially within first tube-like structure 32, or
vice versa. FIG. 3 also illustrates a catheter 34 configured to
introduce annuloplasty device 30 to heart 10. Catheter 34 may be
similar to or substantially the same as any other catheter
described herein, including catheter 26 of FIG. 2.
[0044] First tube-like structure 32 may be similar to or
substantially the same as any other tube-like structures described
herein, including tube-like structure 22 of FIG. 2. In some
examples, first tube-like structure 32 may include a pre-set shape
configured to urge a sidewall of first tube-like structure 32 into
contact with tissue of annulus AN and/or leaflets LF, e.g., a
pre-set structure configured to cause first tube-like structure 32
to return toward a radius of curvature larger than a curvature of
annulus AN.
[0045] Second tube-like structure 36 may include a biocompatible
material in a tubular shape. In some examples, second tube-like
structure 36 may include a biocompatible metal or alloy, such as
nitinol, stainless steel, a cobalt-chromium alloy, or the like. In
some instances, second tube-like structure 36 may include a
biocompatible shape memory alloy.
[0046] Second tube-like structure 36 may include a stent or a
laser-but tube. In either case, second tube-like structure 36 may
include a sidewall defining the shape of second tube-like structure
36 and defining a bore. In some examples, the bore may extend the
length of second tube-like structure 36 from a proximal end of
second tube-like structure 36 to a distal end of second tube-like
structure 36. The sidewall may be shaped and sized such that
another device, such as a cinch wire, a cinch device, a second
tube-like structure, or the like, may extend through the bore for
at least a portion of a length of second tube-like structure
36.
[0047] Additionally, the sidewall of second tube-like structure 36
may be shaped and sized such that second tube-like structure 36 may
be disposed in the bore of first tube-like structure 32. For
example, the sidewall of second tube-like structure 36 may have an
outer diameter or outer circumference that is less than an inner
diameter or an inner circumference of the sidewall of first
tube-like structure 32. In some examples, the side wall of second
tube-like structure 36 may have an outer diameter or outer
circumference that is sufficiently close to the inner diameter or
the inner circumference of the sidewall (e.g., the inner
circumference of the bore) of first tube-like structure 32. First
and second tube-like structures 32, 36 are configured such that
when second tube-like structure 36 is within a bore of first
tube-like structure 32, plurality of anchors 38 extend radially
outward through openings in the sidewall of first tube-like
structure 32 to engage tissue of heart 10 (e.g., annulus AN and/or
leaflets LF).
[0048] In examples in which second tube-like structure 36 includes
a stent, the stent may include any suitable stent construction. For
example, the stent may include a plurality of interwoven filaments
that together define the sidewall of second tube-like structure 36.
As another example, the stent may include a spiral pattern of
crowns and connection nodes configured to provide predetermined
flexibility to second tube-like structure 36. The spiral pattern of
crowns and connection nodes may be formed by cutting a tube to
remove material and leave the spiral pattern of crowns and
connection nodes. As another example, the stent may include another
suitable arrangement of struts.
[0049] A laser cut tube may include at least one cut that serves to
selectively increase flexibility of the laser cut tube. The cuts
may be oriented in a circumferential direction, a longitudinal
direction, or the like. In some examples, the cuts may include
spiral cut(s) that extend around a circumference of second
tube-like structure 36 resulting in the laser cut tube having a
spiral or helical shape.
[0050] In some examples, second tube-like structure 36 may have a
pre-set shape. For example, the pre-set shape may be defined using
a heat treatment. The pre-set shape is a shape toward which second
tube-like structure 36 recovers in the absence of an applied force.
In some examples, the pre-set shape may include a radius of
curvature larger than a curvature of annulus AN, such that the
pre-set shape urges second tube-like structure 36 radially outward
toward walls of annulus AN to enable second tube-like structure 36
to more closely follow the shape of annulus AN. Such a pre-set
shape also may urge the sidewall of first tube-like structure 32
into contact with tissue of heart 10 (e.g., annulus AN and/or
leaflets LF) and may urge the plurality of anchors 38 into
engagement with tissue of heart 10 (e.g., annulus AN and/or
leaflets LF).
[0051] Plurality of anchors 38 may be formed integrally with second
tube-like structure 32 or otherwise attached to second tube-like
structure 32. As used herein, formed integrally means that the
structures are part of a single, inseparable structure. For
example, plurality of anchors 38 may be defined by laser cutting as
part of the process of laser cutting second tube-like structure 32.
In other examples, plurality of anchors 38 may be welded to second
tube-like structure 32, mechanically coupled to second tube-like
structure 32, or the like. Plurality of anchors 38 may have any
suitable shape, including, for example, substantially straight or
curved tines, hooks, helices, double helices, or the like.
[0052] Plurality of anchors 38 are distributed along a length of
second tube-like structure 32. The distribution of anchors 38
affects the points at which force can be applied to tissue of heart
10 via first tube-like structure 32 and anchors 38. In some
examples, plurality of anchors 38 may be distributed substantially
evenly along the length of second tube-like structure 36. In other
examples, plurality of anchors 44 may be distributed unevenly along
the length of tube-like structure 42. Further, second tube-like
structure 36 may extend along at least part of a length of first
tube-like structure 32. In some examples, second tube-like
structure 36 may extend substantially along an entire length of
first tube-like structure 32.
[0053] In some examples, first tube-like structure 32 may have a
pre-set shape that urges plurality of anchors 38 into engagement
with tissue of heart 10, e.g., annulus AN. For example, first
tube-like structure 32 may have a pre-set shape with a radius of
curvature larger than curvature of annulus AN.
[0054] FIG. 4 is a schematic cross-sectional view of an example
human heart 10 and an annuloplasty device 40 including a tube-like
structure 42 that includes a plurality of anchors 44. Tube-like
structure 42 may be similar to or substantially the same as any
other tube-like structures described herein, including tube-like
structure 22, aside from the differences described herein.
[0055] Plurality of anchors 44 may be attached to or formed
integrally with tube-like structure 42. For example, plurality of
anchors 44 may be defined by laser cutting as part of the process
of laser cutting tube-like structure 42. In other examples,
plurality of anchors 44 may be welded to tube-like structure 42,
mechanically coupled to tube-like structure 42, or the like.
Plurality of anchors 44 may have any suitable shape, including, for
example, substantially straight or curved tines, hooks, helices,
double helices, or the like.
[0056] Plurality of anchors 44 may be distributed along a length of
tube-like structure 42. The distribution of anchors 44 affects the
points at which force can be applied to tissue of heart 10 via
tube-like structure 42 and anchors 44. In some examples, plurality
of anchors 44 may be distributed substantially evenly along the
length of tube-like structure 42. In other examples, plurality of
anchors 44 may be distributed unevenly along the length of
tube-like structure 42. For example, plurality of anchors 44 may be
distributed proximate to a distal end of tube-like structure 42 and
proximate to a proximal end of tube-like structure 42 and absent
from a medial portion of tube-like structure 42.
[0057] Plurality of anchors 44 may be movable between an undeployed
configuration and a deployed configuration. In the undeployed
configuration shown in FIG. 4, free ends of plurality of anchors 44
may be oriented toward the bore of tube-like structure 42 such that
plurality of anchors 44 do not engage tissue adjacent to the
sidewall of tube-like structure 42.
[0058] FIG. 5 is a schematic cross-sectional view of an example
human heart 10 and annuloplasty device 40, with the plurality of
anchors 44 in a deployed configuration. In the deployed
configuration, free ends of plurality of anchors 44 are oriented
away from the bore of tube-like structure 42 (i.e., outwards from
sidewall of tube-like structure 42). Plurality of anchors 44 are
configured to engage tissue of heart 10 (e.g., annulus AN and/or
leaflets LF) in the deployed configuration.
[0059] As shown in FIG. 5, in some examples, plurality of anchors
44 may be moved from the undeployed configuration to the deployed
configuration using a delivery device 46. Delivery device 46
includes an elongate member 48 that defines at least one lumen and
an expandable balloon catheter 50. Like delivery device 26, the at
least one lumen may be configured to house and release annuloplasty
device 40 to the treatment site (e.g., adjacent annulus AN).
Further, the at least one lumen may be configured to house and
release balloon catheter 50. Balloon catheter 50 includes an
expandable balloon 52 configured to expand and contract from an
expanded configuration to a contracted configuration and vice versa
under control of a clinician manipulating balloon catheter 50. For
example, expandable balloon 52 may be configured to expand in
response to application of pressure to an interior of expandable
balloon 52, e.g., using a fluid, and contract in response to
removal of the application of pressure to the interior of
expandable balloon 52.
[0060] To move plurality of anchors 44 from the undeployed
configuration to the deployed configuration, balloon catheter 50
may be advanced from delivery device 46 to position expandable
balloon 52 within the bore of tube-like structure 42 adjacent to
one or more anchor of the plurality of anchors 44. Expandable
balloon 52 then may be expanded to exert force again the one or
more anchor and move the one or more anchor from the undeployed
configuration to the deployed configuration. The anchor may be
configured to remain in the deployed configuration, even after
contraction of expandable balloon 52. Expandable balloon 52 then
may be contracted, balloon catheter 50 manipulated to move
expandable balloon 52 adjacent to another one or more anchor of the
plurality of anchors, and expandable balloon 52 expanded to exert
force again the one or more anchor and move the one or more anchor
from the undeployed configuration to the deployed configuration.
This technique may be repeated until all anchors of the plurality
of anchors 44 are in the deployed configuration.
[0061] In some examples, selectively deploying anchors 44 may
facilitate the implantation of annuloplasty device 40 because a
clinician may first confirm annuloplasty device 40 is at a suitable
location within heart 10 before deploying the anchors 44 and fixing
annuloplasty device 40 in place within heart 10.
[0062] In some examples, rather than including a single tube-like
structure 42, the example shown in FIGS. 4 and 5 may include
multiple, distinct tube-like structures deployed using respective
catheters.
[0063] In some examples, a tube-like member may include anchors
that are biased to engage with tissue. For example, FIG. 6 is an
image of an example an annuloplasty device 60 including a tube-like
structure 62 and a plurality of anchors 64 that are biased to
engage with tissue. Tube-like structure 62 may be similar to or
substantially the same as any other tube-like structures described
herein, including tube-like structure 22 of FIG. 2, aside from the
differences described herein. In the example of FIG. 6, tube-like
structure 62 includes a cut tube.
[0064] Tube-like structure 62 also includes plurality of anchors
64. In some examples, plurality of anchors 64 are integral to
tube-like structure 62. In other examples, plurality of anchors 64
are attached to tube-like structure 62. Plurality of anchors 64 are
all oriented with free ends oriented outward away from the bore of
tube-like structure 62 in a single direction, such that, by moving
tube-like structure 62 in the direction of the free ends of the
plurality of anchors 64, the plurality of anchors 64 may be made to
engage tissue of a heart (e.g., tissue of an annulus AN or leaflets
LF (FIGS. 1A and 1B)).
[0065] In other examples, at least some of anchors 64 are
configured to self-expand. When annuloplasty device 60 is
positioned within an inner lumen of an elongate member (e.g.,
elongate member 48 shown in FIG. 5), the anchors 64 may be held in
an undeployed configuration by elongate member 48. As each
self-expandable anchor 64 is deployed from the elongate member of
the delivery device, the respective self-expandable anchor 64 may
expand radially outwards into the deployed configuration.
[0066] A radially inward force may be exerted by or on the
tube-like structure of any one of FIGS. 3-6 using one or more of a
variety of mechanisms. For example, as described above, in some
implementations the tube-like structure may have a pre-set
structure with a radius of curvature less than the radius of
curvature of annulus AN, such that when the tube-like structure is
engaged to the annulus using at least one anchor, the restorative
force caused by the tube-like structure recovering toward its
pre-set shape exerts a radially inward force on the annulus AN.
FIG. 7 is a line diagram of an example annuloplasty device 70
including a tube-like structure 72 and a cinching device 74 in a
bore of tube-like structure 72, illustrating another example
mechanism for exerting a radially inward force on tube-like
structure 72. Tube-like structure 72 may be similar to or
substantially the same as any other tube-like structures described
herein, including tube-like structure 22 of FIG. 2, aside from the
differences described herein.
[0067] Cinching device 74 may include a wire, tube-like device, or
the like, configured to fit within the bore of tube-like structure
72 and exert a radially inward force on tube-like structure 72
(e.g., an interior surface of the sidewall of tube-like structure
72). Cinching device 74 may have a pre-set shape with a radius of
curvature less than the radius of curvature of tube-like structure
72. In this way, cinching device 74 may exert a restorative force
on tube-like structure 72 as cinching device 74 recovers toward its
pre-set shape. In some examples, cinching device 74 may include a
shape memory alloy, such as a Ni--Ti alloy. Cinching device 74 may
extend in the bore along at least a portion of the length of
tube-like structure 72, such as along an entire length of tube-like
structure 72.
[0068] FIG. 8 is a schematic view of an example annuloplasty device
80 including a tube-like structure 82 and a removable stylet 84 in
a bore of tube-like structure 82. Tube-like structure 82 may be
similar to or substantially the same as any other tube-like
structures described herein, including tube-like structure 22 of
FIG. 2, aside from the differences described herein. Removable
stylet 84 may be disposed in the bore of tube-like structure 82
during introduction to the treatment site and engagement of
tube-like structure 82 with tissue using at least one anchor.
Removable styles 84 may include a biocompatible material, such as a
biocompatible shape memory alloy. Removable stylet 84 may have a
pre-set shape with a radius of curvature larger than a radius of
curvature of tube-like structure 82. For example, removable stylet
84 may have a pre-set shape with a radius of curvature that
approximates or is substantially the same as the annulus or other
physiological structure to which tube-like structure 82 is to be
engaged. In this way, removable stylet 84 may facilitate
positioning and engagement of tube-like structure 82 with the
annulus or other physiological structure.
[0069] Once tube-like structure 82 has been positioned and engaged
with tissue, removable stylet 84 may be removed from the bore of
tube-like structure 82. Since tube-like structure 82 has a radius
of curvature than removable stylet 84, removal of removable stylet
84 from the bore of tube-like structure 82 allows tube-like
structure 82 to restore toward its pre-set shape with a smaller
radius of curvature. This exerts a restorative, radially inward
force on the at least one anchor, and, thus, the tissue to which
tube-like structure 82 is engaged.
[0070] FIG. 9A is a schematic partial cross-sectional view of an
example human heart 10 and an example annuloplasty device 90
including a tube-like structure 92, a spiral anchor 94, and a cinch
wire 96. FIG. 9A illustrates posterior wall 102 of the left atrium
100 and anterior and poster leaflets LF. FIG. 9B is a
cross-sectional view of human heart 10 illustrating a portion of
atrial wall AW, annulus AN, and ventricular wall VW. Tube-like
structure 92 may be similar to or substantially the same as any
other tube-like structures described herein, including tube-like
structure 22 of FIG. 2, aside from the differences described
herein.
[0071] In some examples, tube-like structure 92 may have a pre-set
shape that includes a radius of curvature that is larger than a
radius of curvature of annulus AN. In other examples, tube-like
structure 92 may have a pre-set shape that includes a radius of
curvature that is substantially the same as or smaller than a
radius of curvature of annulus AN. Tube-like structure 92 defines a
bore through which cinch wire 96 extends. Further, tube-like
defines a plurality of apertures or through holes through which
spiral anchor 94 extends. Spiral anchor 94 may include any suitable
material, such as any material described herein for a tube-like
structure or anchor. For example, spiral anchor 94 may include a
biocompatible metal or alloy, such as a biocompatible shape memory
alloy, a Ni--Ti alloy, stainless steel, a Co--Cr alloy, or the
like.
[0072] Cinch wire 96 extends through the bore of tube-like
structure 92 from a first end of tube-like structure 92 to a second
end of tube-like structure 92. A first end of cinch wire 96 is
attached to a first helical anchor 98A and a second end of cinch
wire 96 is attached to a second helical anchor 98B (collectively,
"helical anchors 98"). Helical anchors 98 engage tissue of heart
10, such as annulus AN. For example, first helical anchor 98A may
engage tissue of a first trigone and second helical anchor 98B may
engage tissue of a second trigone. In some examples, the first end
of cinch wire 96 may be pre-attached to first helical anchor 98A
and the second end of cinch wire 96 may be attached to second
helical anchor 98B after spiral anchor 94 is deployed and cinch
wire 96 is tightened. Cinch wire 96 may include any suitable
material, such as any material described herein for a tube-like
structure or anchor. For example, cinch wire 96 may include a
biocompatible metal or alloy, such as a biocompatible shape memory
alloy, a Ni--Ti alloy, stainless steel, a Co--Cr alloy, or the
like.
[0073] To deploy annuloplasty device 90, a delivery device may
deploy first helical anchor 98A (with cinch wire 96 pre-attached)
and engage first helical anchor 98A with tissue, such as a first
trigone and/or annulus AN. The delivery device then may deploy
tube-like structure 92 while approximately circumnavigating annulus
AN to help tube-like structure 92 seat on annulus AN. During
deployment of tube-like structure 92, cinch wire 96 already extends
through the bore of tube-like structure 92.
[0074] Once tube-like structure 92 is deployed and seated on
annulus AN, the delivery device may engage spiral anchor 94 with
tube-like structure 92. For example, the delivery device be
manipulated to torque spiral anchor 94 to cause spiral anchor 94 to
spirally advance through the apertures or through holes defined in
tube-like structure 92 while engaging tissue of annulus AN and/or
atrial wall AW. The delivery device may continue to be manipulated
to torque spiral anchor 94 until spiral anchor 94 has engaged
tube-like structure 92 along a predetermined length of tube-like
structure 92, e.g., an entire length of tube-like structure 92.
[0075] After spiral anchor 94 has engaged tube-like structure 92
along the predetermined length of tube-like structure 92, the free
end of cinch wire 96 (e.g., the end not connected to first helical
anchor 98A) may be pulled by the delivery device to tighten
tube-like structure and pull the anchored section of the annulus
toward the helical anchors 98. The delivery device may then crimp
the cinch wire to second helical anchor 98B to hold cinch wire 96
and tube-like structure 92 in the cinched position.
[0076] FIG. 10 is a schematic cross-sectional view of an example
human heart 10 and an example annuloplasty device 110 including a
first tube-like structure 112 and a second tube-like structure 114.
Each of first tube-like structure 112 and second tube-like
structure 114 may be similar to or substantially the same as
tube-like structure 92 of FIG. 9 and may be engaged to a respective
cinch wire and spiral anchor. In other examples, each of first
tube-like structure 112 and second tube-like structure 114 may be
similar to or substantially the same as any other tube-like
structure described herein and may be anchored to tissue using any
anchor(s) described herein. In some examples, a single cinch wire
may extend through the respective bore of both first tube-like
structure 112 and second tube-like structure 114 and be used to
cinch both first tube-like structure 112 and second tube-like
structure 114 toward each other. First tube-like structure 112 is
configured to extend from adjacent a first trigone to adjacent a
second trigone of the cardiac or vascular valve in a first
direction, and second tube-like structure 114 is configured to
extend from adjacent the first trigone to adjacent the second
trigone of the cardiac or vascular valve in a second direction
opposite the first direction. In this way, both sides of the
cardiac or vascular valve may be pulled to respective sets of
helical anchors, increasing coaptation of the valve leaflets.
[0077] FIG. 11 is a flow diagram illustrating an example technique
for implanting an annuloplasty device. The technique of FIG. 11
will be described with concurrent reference to annuloplasty device
20 of FIG. 2, although it will be understood that the technique of
FIG. 11 may be used to implant any of the annuloplasty devices
described herein, and the annuloplasty devices described herein may
be implanted using other techniques.
[0078] First, delivery device 26 may be advanced through
vasculature of a patient to a treatment site (122). For example, a
clinician may introduce delivery device 26 into vasculature of a
patient transcutaneously. For instance, delivery device 26 may be
introduced to a femoral or radial artery. Delivery device 26 may be
advanced through vasculature of the patient to the treatment site
by a clinician manipulating a handle of delivery device 26. In some
examples, delivery device 26 may include a steerable shaft or tip
to allow the clinician to direct delivery device 26 through bends,
curves, and branching points of the vasculature.
[0079] In some examples, the treatment site may include the mitral
valve, and delivery device 26 may be advanced to the left atrium.
In other examples, the treatment site may include another heart
valve. Delivery device 26 may access the left atrium
trans-septally, trans-aortically, or trans-apically. In some
examples, delivery device 26 may be tracked over a guide wire,
through a guide catheter, or the like as delivery device 26 is
advanced to the treatment site. Delivery device 26 may include one
or more radiological markers at or near a distal end of delivery
device 26 to assist visualizing delivery device 26 as delivery
device is advanced to the treatment site.
[0080] Once delivery device 26 (e.g., a distal portion of delivery
device 26) has been advance to the treatment site, delivery device
26 may release annuloplasty device 20, including tube-like
structure 22 and the at least one anchor (124). The particular way
in which tube-like structure 22 is released by delivery device 26
may depend on the configuration of tube-like structure, the at
least one anchor, and whether a cinch wire, cinch device, or stylet
is present. Examples of how delivery device 26 releases
annuloplasty device 20 are described throughout this disclosure and
may be used alone or in any combination depending on the
configuration of the annuloplasty device.
[0081] Releasing annuloplasty device 20 may include, for example,
allowing tube-like structure 22 to return toward its pre-set shape
in examples in which tube-like structure has a pre-set shape. As
described above, the pre-set shape may be configured to decrease a
distance between valve leaflets LF that extend from the annulus AN.
Releasing annuloplasty device 20 additionally or alternatively may
include moving the at least one anchor between an undeployed
configuration in which the at least one anchor extends generally
inward into a bore of tube-like structure 22 and a deployed
configuration in which the at least one anchor extends generally
outward away from the bore of the tube-like structure 22. In some
examples, releasing annuloplasty device 20 may include expanding an
expandable balloon 52 (FIG. 5) to exert a force on the at least one
anchor to cause the at least one anchor to move from an undeployed
configuration to a deployed configuration.
[0082] In some examples, releasing annuloplasty device 20 may
include removing a removable stylet 84 (FIG. 8) from the bore of
tube-like structure 22 to allow tube-like structure 22 to recover
toward a pre-set shape having a smaller radius of curvature than a
radius of curvature of the removable stylet 84. In some examples,
releasing annuloplasty device 20 from the lumen of delivery device
26 may allow a cinch device 74 (FIG. 7) disposed in the bore of
tube-like structure 22 to urge tube-like structure 22 toward
smaller radius of curvature.
[0083] The following clauses illustrate example subject matter
disclosed herein.
[0084] Clause 1. An annuloplasty device comprising: a tube-like
structure configured to extend around at least part of a
circumference of an annulus of a cardiac or vascular valve; and at
least one anchor configured to anchor the tube-like structure to
the annulus, wherein the tube-like structure is configured to
decrease a distance between valve leaflets that extend from the
annulus.
[0085] Clause 2. The annuloplasty device of clause 1, wherein the
tube-like structure comprises a biocompatible shape memory
alloy.
[0086] Clause 3. The annuloplasty device of clause 1, wherein the
tube-like structure comprises at least one of a nickel-titanium
alloy, stainless steel, or a cobalt-chromium alloy.
[0087] Clause 4. The annuloplasty device of any one of clauses 1 to
3, wherein the tube-like structure comprises at least one of a
stent or a cut tube.
[0088] Clause 5. The annuloplasty device of clause 4, wherein the
tube-like structure comprises the stent, and wherein the stent
comprises a spiral pattern of crowns and connection nodes.
[0089] Clause 6. The annuloplasty device of clause 4, wherein the
tube-like structure comprises the cut tube, and wherein the cuts
extend in at least one of circumferential or longitudinal
directions of the cut tube.
[0090] Clause 7. The annuloplasty device of clause 6, wherein at
least some of the cuts comprise spiral cuts extending around a
circumference of the tube-like structure.
[0091] Clause 8. The annuloplasty device of any one of clauses 1 to
7, wherein the tube-like structure has a pre-set shape.
[0092] Clause 9. The annuloplasty device of clause 8, wherein the
pre-set shape is configured to urge at least some anchors of the
plurality of anchors toward each other in a radially inward
direction to decrease a distance between valve leaflets that extend
from the annulus.
[0093] Clause 10. The annuloplasty device of clause 8, wherein the
pre-set shape is configured to urge at least some anchors of the
plurality of anchors away from each other in a radially outward
direction.
[0094] Clause 11. The annuloplasty device of any one of clauses 1
to 10, wherein the tube-like structure is a first tube-like
structure, further comprising a second tube-like structure
coaxially arranged within the first tube-like structure, wherein
the second tube-like structure comprises the at least one
anchor.
[0095] Clause 12. The annuloplasty device of clause 11, wherein the
at least one anchor extends radially outward through the first
tube-like structure, and wherein the first tube-like structure
urges the at least one anchor to engage with tissue.
[0096] Clause 13. The annuloplasty device of any one of clauses 1
to 10, wherein the tube-like structure comprises the at least one
anchor.
[0097] Clause 14. The annuloplasty device of clause 13, wherein the
at least one anchor is configured to move between an undeployed
configuration in which the at least one anchor extends generally
inward into a bore of the tube-like structure and a deployed
configuration in which the at least one anchor extends generally
outward away from the bore of the tube-like structure.
[0098] Clause 15. The annuloplasty device of clause 13, wherein the
at least one anchor is biased to extend in a first direction
relative to a longitudinal axis of the tube-like structure and
extend generally outward away from the bore of the tube-like
structure.
[0099] Clause 16. The annuloplasty device of any one of clauses 1
to 10, wherein the at least one anchor comprises a spiral anchor
configured to extend spirally through holes in the tube-like
structure.
[0100] Clause 17. The annuloplasty device of any one of clauses 1
to 16, further comprising a cinch wire extending through a bore of
the tube-like device.
[0101] Clause 18. The annuloplasty device of clause 17, wherein the
cinch wire extends through the bore from a first end of the
tube-like device to a second end of the tube-like device.
[0102] Clause 19. The annuloplasty device of clause 17 or 18,
wherein the at least one anchor comprise a first anchor coupled to
a first end of the cinch wire and a second anchor coupled to a
second end of the cinch wire, opposite the first end of the cinch
wire.
[0103] Clause 20. The annuloplasty device of any one of clauses 1
to 16, further comprising a cinch device disposed in a bore of the
tube-like structure, wherein the cinch device has a pre-set shape
with a smaller radius of curvature than the tube-like
structure.
[0104] Clause 21. The annuloplasty device of clause 20, wherein the
cinch device comprises at least one of a shaped wire, a shaped
stent, or a shaped tube.
[0105] Clause 22. The annuloplasty device of any one of clauses 1
to 16, further comprising a removable stylet, wherein the removable
stylet comprises a pre-set shape approximating a shape of the
annulus, wherein the removable stylet is removably disposed in a
bore of the tube-like structure, and wherein removal of the
removable stylet from the bore allows the tube-like structure to
recover toward a pre-set shape having a smaller radius of curvature
than a radius of curvature of the removable stylet.
[0106] Clause 23. The annuloplasty device of any one of clauses 1
to 22, wherein the tube-like structure is configured to extend from
adjacent a first trigone to a second trigone of the cardiac or
vascular valve.
[0107] Clause 24. The annuloplasty device of any one of clauses 1
to 22, wherein the tube-like structure is configured to extend
around substantially an entire circumference of the annulus.
[0108] Clause 25. The annuloplasty device of any one of clauses 1
to 22, wherein the tube-like structure is a first tube-like
structure configured to extend from adjacent a first trigone to a
second trigone of the cardiac or vascular valve in a first
direction, further comprising a second tube-like structure
configured to extend from adjacent the first trigone to adjacent
the second trigone of the cardiac or vascular valve in a second
direction opposite the first direction.
[0109] Clause 26. The annuloplasty device of any one of clauses 1
to 25, wherein the cardiac or vascular valve comprises a mitral
valve comprising a mitral annulus, an anterior valve leaflet, and a
posterior valve leaflet, and wherein the tube-like structure is
configured to extend around a circumference of the mitral annulus
from proximate the anterior valve leaflet to proximate the
posterior valve leaflet.
[0110] Clause 27. A system comprising: a delivery device configured
to access vasculature of a patient; and the annuloplasty device of
any one of clauses 1 to 26, wherein the delivery device is
configured to house the annuloplasty device in a lumen and deliver
the annuloplasty device to the annulus of the cardiac or vascular
valve and engage the anchors to the annulus.
[0111] Clause 28. The system of clause 27, wherein the delivery
device comprises a steerable shaft.
[0112] Clause 29. The system of clause 27 or 28, wherein the
delivery device is configured to exert a force on the anchor to
engage the anchor with the annulus.
[0113] Clause 30. The system of any one of clauses 27 to 29,
wherein the anchor comprises the spiral anchor configured to extend
spirally through holes in the tube-like structure, and wherein the
delivery device is configured to torque the spiral anchor to
advance the spiral anchor in engagement with the tube-like
structure.
[0114] Clause 31. The system of any one of clauses 27 to 30,
wherein the delivery device is configured to manipulate the cinch
device to reduce a radius of curvature of the tube-like
structure.
[0115] Clause 32. A method comprising: advancing a delivery device
through vasculature of a patient to a vascular or cardiac treatment
site, wherein the delivery device comprises a lumen housing an
annuloplasty device, wherein the annuloplasty device comprises: a
tube-like structure configured to extend around at least part of a
circumference of an annulus of a cardiac or vascular valve; and at
least one anchor configured to anchor the tube-like structure to
the annulus, wherein the tube-like structure is configured to
decrease a distance between valve leaflets that extend from the
annulus; and releasing the annuloplasty device from the lumen to
extend around at least part of a circumference of an annulus of a
cardiac or vascular valve.
[0116] Clause 33. The method of clause 32, wherein the tube-like
structure comprises a biocompatible shape memory alloy.
[0117] Clause 34. The method of clause 32, wherein the tube-like
structure comprises at least one of a nickel-titanium alloy,
stainless steel, or a cobalt-chromium alloy.
[0118] Clause 35. The method of any one of clauses 32 to 34,
wherein the tube-like structure comprises at least one of a stent
or a cut tube.
[0119] Clause 36. The method of clause 35, wherein the tube-like
structure comprises the stent, and wherein the stent comprises a
spiral pattern of crowns and connection nodes.
[0120] Clause 37. The method of clause 35, wherein the tube-like
structure comprises the cut tube, and wherein the cuts extend in at
least one of circumferential or longitudinal directions of the
laser cut tube.
[0121] Clause 38. The method of clause 37, wherein at least some of
the cuts comprise spiral cuts extending around a circumference of
the tube-like structure.
[0122] Clause 39. The method of any one of clauses 32 to 38,
wherein the tube-like structure has a pre-set shape, wherein the
delivery device urges the tube-like structure away from the pre-set
shape, and wherein releasing the annuloplasty device from the lumen
allows the tube-like structure to return toward the pre-set
shape.
[0123] Clause 40. The method of clause 39, wherein the pre-set
shape is configured to decrease a distance between valve leaflets
that extend from the annulus.
[0124] Clause 41. The method of any one of clauses 32 to 40,
wherein the tube-like structure is a first tube-like structure,
further comprising a second tube-like structure coaxially arranged
within the first tube-like structure, wherein the second tube-like
structure comprises the at least one anchor, and wherein releasing
the annuloplasty device from the lumen allows the first tube-like
structure to urge the at least one anchor to engage with
tissue.
[0125] Clause 42. The method of any one of clauses 32 to 40,
wherein the tube-like structure comprises the at least one anchor,
and wherein releasing the annuloplasty device from the lumen allows
the tube-like structure to deform to urge the at least one anchor
to engage with tissue.
[0126] Clause 43. The method of any one of clauses 32 to 40,
wherein the tube-like structure comprises the at least one anchor,
wherein releasing the annuloplasty device from the lumen comprises
moving the at least one anchor between an undeployed configuration
in which the at least one anchor extends generally inward into a
bore of the tube-like structure and a deployed configuration in
which the at least one anchor extends generally outward away from
the bore of the tube-like structure.
[0127] Clause 44. The method of clause 43, wherein the delivery
device further comprises a balloon catheter, and wherein moving the
at least one anchor between the undeployed configuration and the
deployed configuration comprises expanding the balloon to exert a
force on the at least one anchor.
[0128] Clause 45. The method of any one of clauses 32 to 40,
wherein the tube-like structure comprises the at least one anchor,
wherein the at least one anchor is biased to extend in a first
direction relative to a longitudinal axis of the tube-like
structure and extend generally outward away from the bore of the
tube-like structure, and wherein releasing the annuloplasty device
from the lumen comprises exerting a force on the tube-like
structure in a direction of the bias to cause the at least one
anchor to engage with tissue.
[0129] Clause 46. The method of any one of clauses 32 to 40,
wherein the at least one anchor comprises a spiral anchor
configured to extend spirally through holes in the tube-like
structure, and wherein releasing the annuloplasty device from the
lumen comprises torqueing the spiral anchor with the delivery
device to advance the spiral anchor in engagement with the
tube-like structure and engage the spiral anchor with tissue.
[0130] Clause 47. The method of any one of clauses 32 to 46,
wherein the annuloplasty device further comprises a cinch wire
extending through a bore of the tube-like device.
[0131] Clause 48. The method of clause 47, wherein the cinch wire
extends through the bore from a first end of the tube-like device
to a second end of the tube-like device.
[0132] Clause 49. The method of clause 47 or 48, wherein the at
least one anchor comprise a first anchor coupled to a first end of
the cinch wire and a second anchor coupled to a second end of the
cinch wire, opposite the first end of the cinch wire, and wherein
releasing the annuloplasty device from the lumen comprises engaging
the first anchor and the second anchor to tissue.
[0133] Clause 50. The method of any one of clauses 47 to 49,
wherein releasing the annuloplasty device comprises exerting a
force on the cinch wire to cause the tube-like structure to
decrease the distance between the valve leaflets that extend from
the annulus.
[0134] Clause 51. The method of any one of clauses 32 to 46,
wherein the annuloplasty device further comprises a cinch device
disposed in a bore of the tube-like structure, wherein the cinch
device has a pre-set shape with a smaller radius of curvature than
the tube-like structure, and wherein releasing the annuloplasty
device from the lumen allows the cinch device to urge the tube-like
structure toward the smaller radius of curvature.
[0135] Clause 52. The method of clause 51, wherein the cinch device
comprises at least one of a shaped wire, a shaped stent, or a
shaped tube.
[0136] Clause 53. The method of any one of clauses 32 to 46,
wherein the annuloplasty device further comprises a removable
stylet, wherein the removable stylet comprises a pre-set shape
approximating a shape of the annulus, wherein the removable stylet
is removably disposed in a bore of the tube-like structure, and
wherein releasing the annuloplasty device from the lumen comprises
removing the removable stylet from the bore to allow the tube-like
structure to recover toward a pre-set shape having a smaller radius
of curvature than a radius of curvature of the removable
stylet.
[0137] Clause 54. The method of any one of clauses 32 to 53,
wherein the tube-like structure is configured to extend from
adjacent a first trigone to a second trigone of the cardiac or
vascular valve, and wherein releasing the annuloplasty device from
the lumen comprises tracking the delivery device from the first
trigone to the second trigone.
[0138] Clause 55. The method of any one of clauses 32 to 53,
wherein the tube-like structure is configured to extend around
substantially an entire circumference of the annulus, and wherein
releasing the annuloplasty device from the lumen comprises tracking
the delivery device around substantially the entire circumference
of the annulus.
[0139] Clause 56. The method of any one of clauses 32 to 54,
wherein the tube-like structure is a first tube-like structure
configured to extend from adjacent a first trigone to a second
trigone of the cardiac or vascular valve in a first direction,
wherein releasing the annuloplasty device from the lumen comprises
tracking the delivery device from the first trigone to the second
trigone while releasing the first tube-like structure, further
comprising tracking the delivery device from adjacent the first
trigone to the second trigone of the cardiac or vascular valve in a
second direction opposite the first direction while releasing a
second tube-like structure.
[0140] Clause 57. The method of any one of clauses 32 to 56,
wherein the cardiac or vascular valve comprises a mitral valve
comprising a mitral annulus, an anterior valve leaflet, and a
posterior valve leaflet, and wherein the tube-like structure is
configured to extend around a circumference of the mitral annulus
from proximate the anterior valve leaflet to proximate the
posterior valve leaflet.
[0141] Various examples have been described. These and other
examples are within the scope of the following claims.
* * * * *